Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section

Analgesia Clinical Trial

Official title:

Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136118
• Other study ID #: R 86/2021
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 25, 2022

Study information

• Verified date: October 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures.

Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.

Description:

Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean Section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: October 25, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• ASA physical status I and ?

• primigravidas

• aged 21-40 years

• BMI ? 40

• body weight ? 60 kg

• singleton pregnancy

• gestational age of =37 weeks

• undergoing elective caesarean section under spinal anesthesia.

Exclusion Criteria:

• Parturient refusal

• parturient with a BMI > 40

• body weight < 60 kg

• ASA physical status = III

• known local anesthetic (LA) allergy •contraindications to spinal anesthesia

• parturients who received analgesics in the past 24 hours

• infection at the site of the block.

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• TAPB
TAPB will be given to parturients whether by the modified surgeon assisted approach or by the ultra-sound guided approach.

Locations

Country	Name	City	State
Egypt	Ain-Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to rescue analgesia	the time from the end of surgery until the first parturient's request for analgesia	6 months
Secondary	Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia	assessment of pain intensity at rest and on passive flexion of the hip and knee by the Numeric Pain Rating Score (NPRS) from 0 = no pain to 10 = worst pain. Assessment will be done at 2, 6, 12 and 24h postoperative.	6 months
Secondary	Number of parturients requiring postoperative analgesia	defined as pethidine needed by each parturient in the 24 hours postoperative period	6 months
Secondary	Total dose of pethidine given	defined as pethidine needed by each parturient in the 24 hours postoperative period	6 months
Secondary	Time to the parturient's first ambulation	the time to start of each parturient movement in the 24 hours postoperative period	6 months
Secondary	The analgesic satisfaction 24 hours after operation	parturients will be asked to report their satisfaction with pain management, assessed as 0 = weak, 1 = medium, 2 = good, 3 = very good, and 4 = excellent.	6 months